US7828818B2 - Heart septal defect occlusion devices with adjustable length tether adapting to the unique anatomy of the patient - Google Patents
Heart septal defect occlusion devices with adjustable length tether adapting to the unique anatomy of the patient Download PDFInfo
- Publication number
- US7828818B2 US7828818B2 US11/307,178 US30717806A US7828818B2 US 7828818 B2 US7828818 B2 US 7828818B2 US 30717806 A US30717806 A US 30717806A US 7828818 B2 US7828818 B2 US 7828818B2
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- United States
- Prior art keywords
- disc
- skeletons
- metal mesh
- discs
- skeleton
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00615—Implements with an occluder on one side of the opening and holding means therefor on the other
Definitions
- the present invention relates to an occlusion device for treating congenital heart disease, such as patent foramen ovale (PFO), atrial septal defect (ASD), patent ductus arteriosus (PDA) or ventricular septal defect (VSD), etc.
- PFO patent foramen ovale
- ASD atrial septal defect
- PDA patent ductus arteriosus
- VSD ventricular septal defect
- Congenital heart diseases include patent foramen ovale (PFO), atrial septal defect (ASD), patent ductus arteriosus (PDA) and ventricular septal defect (VSD), etc.
- PFO and ASD are openings in the wall between the right atrium and left atrium of the heart thereby creating the possibility that the blood could pass from the right atrium to the left atrium.
- the defect size of PFO is usually smaller than that of ASD and the defect will not extend perpendicularly to the septal wall, i.e. left atrial septal defect is not concentric with that of the right atrium.
- the occluder Once the occluder has been placed, it will prevent the thrombus from entering into the left atrium.
- the atrial septal defect (ASD) is usually larger and requires repair.
- endocardiac occlusion devices for treating congenital heart diseases. These occluders are delivered to the desired location by a corresponding catheter.
- the two discs are a whole, they cannot automatically adjust the angle to adapt to the unique anatomy of the patient. Meanwhile, if the left disc is not deployed completely the operation becomes more complicated.
- the present invention provides a reliable occlusion device with adjustable length tether which can adapt the interseptal length of the device to the unique anatomy of the patient.
- the two discs can attach to the septal defect closely, so they can improve the closing ability.
- thrombus can be reduced because its left disc is covered with membranes and operate more easily.
- the present invention provides an occlusion device where the right disc is made from a double-deck wire mesh with contraction function, and the left disc is made from at least two skeletons covered with membranes, and the two discs are adaptively interlocked together by the skeletons passing through the mesh of the right disc.
- each skeleton is U shape, and the depths of the U trough are different, so the skeleton can form a plane after being linked together.
- the skeleton is then covered with membranes to form a disc shape.
- the left disc is made from several radially-extending skeletons by heat treatment, and covered with membranes, and the center of each skeleton extends radially after overlapping together.
- each skeleton is spherical shaped and are wrapped by the membranes, and the ends of the right disc are fixed by a tip or a joint, then the right disc undergoes heat treatment. Then the skeletons pass through the mesh near the tip and are overlapped together.
- the membranes are made from biocompatible materials.
- the device can adapt to the interseptal length between two discs for the unique anatomy of the patient. Therefore, the two discs may attach to the heart defects closely and increase its closing ability. Moreover, the occlusion device can reduce the thrombus as well as harmful elements because of its left disc being covered with membranes. In addition, the device, which is fission structure, (i.e. its two discs could deploy completely), is easy to operate and increases the closing reliability.
- FIG. 1 is a schematic representation of a disc which is constructed by skeletons in accordance with the invention.
- FIG. 2 is a side view of the right disc in accordance with the invention.
- FIG. 3 is a side view of the skeleton in accordance with the invention.
- FIG. 4 is a side view of the occlusion device in accordance with the invention.
- FIG. 5 is an enlarged partial sectional view of part A as shown in FIG. 4 .
- FIG. 6 is a front view of the occlusion device in accordance with the invention.
- FIG. 7 and FIG. 8 are alternative embodiments of skeletons.
- FIG. 9 is a side view of the membrane, which is used to cover the skeletons in accordance with the invention.
- FIG. 10 is a side view of the skeletons, which have been covered with membranes such as shown in FIG. 9 .
- FIG. 11 is a schematic representation of a mould, which is used to heat-treat the skeletons.
- FIG. 12 is a schematic representation of a PFO occluder being released from a delivery catheter.
- FIG. 13 is a schematic representation of an ASD occluder being released from a delivery catheter.
- the present invention provides a heart septal defect occlusion device for occluding an anatomical aperture, such as a patent foramen ovale occluder shown in FIG. 4 .
- the occluder comprises right disc 21 (i.e. metal mesh disc), tip 22 , joint 23 , left disc 1 which is covered with membranes, and membranes 100 , as shown in FIG. 1 and FIG. 9 .
- the present invention will be described using a PFO occluder as an example.
- the maximal character of the PFO occluder when compared with those of the above-referenced patents, is that the left disc 1 comprises six skeletons 11 which are spaced apart evenly. And the six skeletons are linked together in the center and form a radial-extending disc. It is possible that the left disc 1 may comprise at least two skeleton 11 as shown in FIG. 3 , and skeleton 11 is made from nitinol wire with shape memory.
- FIG. 3 The maximal character of the PFO occluder, when compared with those of the above-referenced patents, is that the left disc 1 comprises six skeletons 11 which are spaced apart evenly. And the six skeletons are linked together in the center and form a radial-extending disc. It is possible that the left disc 1 may comprise at least two skeleton 11 as shown in FIG. 3 , and skeleton 11 is made from nitinol wire with shape memory
- the mould which is used to heat treat skeletons 11 ;
- the mould includes upper-mould 201 , middle-mould 202 and under-mould 203 and the nitinol wire will be put into the rabbet of the middle-mould 202 .
- the crystal structure of the nitinol wire can be reset in the austenitic phase, and this will tend to “set” the shape of the device, (i.e., it can keep the shape when it is fixed in the mould).
- the wire can keep the “set” shape even if cooled, and when the outside force is withdrawn, it can resume its original shape.
- the middle segment of the skeleton 11 is U shape, and the depth of each U trough is different. By providing different depth U troughs for each skeleton 11 , these skeletons can form a plane after they have been overlapped together.
- the skeletons 11 are then covered with membranes to form the left disc 1 .
- the right disc 21 of a PFO occluder uses moulding components. Firstly, the suitable tubular metal mesh of the PFO occluder is formed by weaving or laser carving, then the tubular metal mesh is inserted into the mould and undergoes heat treatment. And, the tip 22 and joint 23 are welded to the disc as shown in FIG. 2 .
- the skeleton 11 as shown in FIG. 3 is passed through the right disc 21 and near the tip 22 , and then a double-disc structure is formed as shown in FIG. 5 . And as shown in FIG. 6 , the skeletons 11 are spaced apart evenly. Accordingly, these skeletons 11 form a metal disc as shown in FIG. 4 .
- FIG. 9 illustrates the skeleton 11 with covered membranes 100 .
- the membranes are made from biocompatible materials. As described above, the spheres of each skeleton are wrapped in the biocompatible materials, so that it can prevent skeleton 11 from puncturing the membranes 100 .
- Another membrane made by biocompatible material 24 is filled into the right disc 21 .
- FIG. 7 illustrates another embodiment of a skeleton 11 having a plurality of separate spokes 12 connected (e.g., by welding or clamping) to a central cap 121
- FIG. 8 illustrates yet another embodiment where a plurality of spokes 13 are attached directly on a tip 22 which can be the same as the tip 22 shown in FIGS. 2 , 4 and 5 .
- the occlusion device as described above may be extended and put into a catheter, and is delivered to the desired location, then is released.
- the tapered waist of the device not only ensures its self-centricity but also can reduce the probability of bad occlusion effect resulting from selection error.
- the left disc 1 which comprises skeletons and membranes, can decrease metal surface areas, thereby decreasing thrombus formation as well as harmful elements.
- the two discs are both individual components and can deploy completely after release of the occlusion device, and this can avoid forming cucurbit shape and increase the reliability of the desired occlusion.
- FIG. 12 and FIG. 13 illustrate the deployment process of an FPO occluder and an ASD occluder during operation respectively. Moreover, the occluder has excellent self-centricity because the right disc 21 is close to the left disc 1 .
- the present invention is also suitable for treating PDA and VSD etc.
- the only difference from above other occluders is that the metal mesh of the PDA occluder of the present invention will not form a disc, but a “waist”.
Abstract
Description
Claims (17)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/927,194 US8366743B2 (en) | 2005-01-28 | 2010-11-08 | Heart septal defect occlusion device |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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CN200510032924 | 2005-01-28 | ||
CN200510032924.0 | 2005-01-28 | ||
CNB2005100329240A CN100389732C (en) | 2005-01-28 | 2005-01-28 | Heart septal defect stopper with self regulating function |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/927,194 Continuation-In-Part US8366743B2 (en) | 2005-01-28 | 2010-11-08 | Heart septal defect occlusion device |
Publications (2)
Publication Number | Publication Date |
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US20060200196A1 US20060200196A1 (en) | 2006-09-07 |
US7828818B2 true US7828818B2 (en) | 2010-11-09 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US11/307,178 Active 2027-10-29 US7828818B2 (en) | 2005-01-28 | 2006-01-26 | Heart septal defect occlusion devices with adjustable length tether adapting to the unique anatomy of the patient |
Country Status (2)
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US (1) | US7828818B2 (en) |
CN (1) | CN100389732C (en) |
Cited By (7)
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CN109069220A (en) * | 2016-03-11 | 2018-12-21 | Cerus血管内设备有限公司 | plugging device |
US11284901B2 (en) | 2014-04-30 | 2022-03-29 | Cerus Endovascular Limited | Occlusion device |
US11406404B2 (en) | 2020-02-20 | 2022-08-09 | Cerus Endovascular Limited | Clot removal distal protection methods |
US11471162B2 (en) | 2015-12-07 | 2022-10-18 | Cerus Endovascular Limited | Occlusion device |
US11517319B2 (en) | 2017-09-23 | 2022-12-06 | Universität Zürich | Medical occluder device |
US11812971B2 (en) | 2017-08-21 | 2023-11-14 | Cerus Endovascular Limited | Occlusion device |
US11944315B2 (en) | 2019-09-26 | 2024-04-02 | Universität Zürich | Left atrial appendage occlusion devices |
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US8617205B2 (en) | 2007-02-01 | 2013-12-31 | Cook Medical Technologies Llc | Closure device |
WO2008094691A2 (en) * | 2007-02-01 | 2008-08-07 | Cook Incorporated | Closure device and method for occluding a bodily passageway |
WO2008094706A2 (en) | 2007-02-01 | 2008-08-07 | Cook Incorporated | Closure device and method of closing a bodily opening |
US8734483B2 (en) * | 2007-08-27 | 2014-05-27 | Cook Medical Technologies Llc | Spider PFO closure device |
CN101449986B (en) * | 2007-11-28 | 2011-08-31 | 王涛 | Obturator of aorta ductus arteriosus |
CN101966092B (en) * | 2010-09-16 | 2012-10-10 | 先健科技(深圳)有限公司 | Medical plugging device |
EP2627265B8 (en) | 2010-10-15 | 2019-02-20 | Cook Medical Technologies LLC | Occlusion device for blocking fluid flow through bodily passages |
CN102440810B (en) * | 2011-01-28 | 2014-02-12 | 先健科技(深圳)有限公司 | Heart defect amplatzer |
WO2013120082A1 (en) | 2012-02-10 | 2013-08-15 | Kassab Ghassan S | Methods and uses of biological tissues for various stent and other medical applications |
CN104905829B (en) * | 2013-02-04 | 2018-07-27 | 先健科技(深圳)有限公司 | A kind of plugging device of the flat disk with included-angle-changeable |
EP2953580A2 (en) | 2013-02-11 | 2015-12-16 | Cook Medical Technologies LLC | Expandable support frame and medical device |
US11911258B2 (en) * | 2013-06-26 | 2024-02-27 | W. L. Gore & Associates, Inc. | Space filling devices |
CN106333723B (en) * | 2015-07-09 | 2020-09-29 | 先健科技(深圳)有限公司 | Ventricular septum and method of making same |
CN108926370B (en) * | 2017-05-23 | 2024-04-16 | 杭州德诺电生理医疗科技有限公司 | Left auricle plugging device capable of improving sealing effect and assembling method thereof |
CN109758194B (en) * | 2019-02-27 | 2020-06-26 | 武汉唯柯医疗科技有限公司 | Atrial septum plugging device |
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US3874388A (en) | 1973-02-12 | 1975-04-01 | Ochsner Med Found Alton | Shunt defect closure system |
US5451235A (en) * | 1991-11-05 | 1995-09-19 | C.R. Bard, Inc. | Occluder and method for repair of cardiac and vascular defects |
US20040117032A1 (en) | 1993-02-22 | 2004-06-17 | Roth Alex T. | Devices for less-invasive intracardiac interventions |
US5683411A (en) * | 1994-04-06 | 1997-11-04 | William Cook Europe A/S | Medical article for implantation into the vascular system of a patient |
US5944738A (en) * | 1998-02-06 | 1999-08-31 | Aga Medical Corporation | Percutaneous catheter directed constricting occlusion device |
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Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11284901B2 (en) | 2014-04-30 | 2022-03-29 | Cerus Endovascular Limited | Occlusion device |
US11389174B2 (en) | 2014-04-30 | 2022-07-19 | Cerus Endovascular Limited | Occlusion device |
US11471162B2 (en) | 2015-12-07 | 2022-10-18 | Cerus Endovascular Limited | Occlusion device |
CN109069220A (en) * | 2016-03-11 | 2018-12-21 | Cerus血管内设备有限公司 | plugging device |
US11648013B2 (en) | 2016-03-11 | 2023-05-16 | Cerus Endovascular Limited | Occlusion device |
US11812971B2 (en) | 2017-08-21 | 2023-11-14 | Cerus Endovascular Limited | Occlusion device |
US11517319B2 (en) | 2017-09-23 | 2022-12-06 | Universität Zürich | Medical occluder device |
US11944315B2 (en) | 2019-09-26 | 2024-04-02 | Universität Zürich | Left atrial appendage occlusion devices |
US11406404B2 (en) | 2020-02-20 | 2022-08-09 | Cerus Endovascular Limited | Clot removal distal protection methods |
Also Published As
Publication number | Publication date |
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US20060200196A1 (en) | 2006-09-07 |
CN100389732C (en) | 2008-05-28 |
CN1810219A (en) | 2006-08-02 |
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